Improving the Approach to and Management of the Older Patient With Metastatic Gastric Cancer

The purpose of this study is to enhance the care of older metastatic gastric cancer (mGC) patients by increasing awareness among oncology providers of the unique aspects of care required for older patients. The goal of the study is to educate providers on the utility of geriatric assessment in guiding therapy of older mGC patients. The investigators will also assess the feasibility and benefit of incorporating geriatric self-assessments into clinical practice. The study will include four phases.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Gastric Cancer
• Intervention / Treatment: Behavioral: Didactic Session; Behavioral: Comprehensive Geriatric Assessment, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status.

Detailed Description

Older oncology patients pose a significant treatment challenge due to poor chemotherapy tolerance as a result of underlying co-morbidities, lack of social support, and diminished functional reserve. Oncologists are faced with the challenge of differentiating between patients that can and cannot tolerate chemotherapy, and tailoring therapy to the patient's biologic rather than chronologic age.

A significant challenge that surrounds the treatment of the older metastatic gastric cancer (mGC) patient in particular, lies in the lack of evidence based clinical data to guide the oncologist in determination of a treatment plan. This is a result of under representation of older patients in clinical trials. Due to these challenges, a thorough evaluation of the older patient is recommended prior to initiation of anti-cancer therapy.

The purpose of this research study is to enhance the care of the older mGC patient by increasing awareness among oncology providers of the unique aspects of care required for older patients. The goal of the study is to educate providers on the utility of geriatric assessment in guiding therapy of older metastatic gastric cancer patients. The investigators will also assess the feasibility and benefit of incorporating geriatric self-assessments into clinical practice. The study will include four phases:

1. Needs assessments - to understand the population of older gastric cancer patients seen in routine practice at community and academic centers, and assess their treatment approach.
2. Educational programming about management of older metastatic gastric cancer patients, and geriatric assessment of these patients.
3. Active testing of the use of geriatric assessment in clinical practice, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status.
4. Short-term follow-up chart reviews (2-3 months post intervention) to assess for actual implementation of recommended interventions identified by the geriatric assessment.

The ultimate goal is to expand this educational intervention to other oncology practices beyond those participating in this study, and for all older cancer patients regardless of their disease site. During this study period we will identify the specific gaps that exist in each practice for the care of older patients with mGC. This information is crucial to understand the needs of this patient population and will inform future trials with possible intervention. The second phase of our study will expose the practices to the use of a geriatric assessment through a patient's self-assessment tool and demonstrate its feasibility. Our hope is that all involved practices will find benefit from incorporating a geriatric assessment into their practice and will continue to use it in the future.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Recruiting
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19140
      • Not yet recruiting
      • Temple University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ability to read and understand English, ability to sign consent, and complete a self-assessment evaluation.
2. Evidence of mGC (mGE junction cancer allowed). Patients can be enrolled at any stage of their treatment or disease course.
3. Ongoing active therapy for mGC. Patients can be treated with any type of therapy including chemotherapy, immunotherapy or Her-2 targeted therapy.
4. Life expectancy ≥3 months.

Exclusion Criteria:

1. ≤69 years old.
2. Inability to read and understand English.
3. No evidence of mGC.
4. Not on active therapy.
5. Life expectancy <3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Provider Didactic Intervention; Phase 1 - Providers complete a needs assessment questionnaire, which evaluates the approach to older mGC patients at each site.; Phase 2 - Providers participate in an hour-long didactic session and begin enrolling eligible metastatic gastric cancer (mGC) patients. Enrolled mGC patients complete a comprehensive geriatric assessment (CGA). Providers complete the treatment plan and review of geriatric assessment questionnaires, which also includes an evaluation of their overall view of the utility of the geriatric assessment.; Phase 3 - Follow-up chart reviews (2-3 months post intervention) are completed to assess for actual implementation of recommended interventions identified by the geriatric assessment.

Behavioral: Didactic Session; This session will include an overview of the approach to and management of older mGC patients patients through a case-based presentation.; Behavioral: Comprehensive Geriatric Assessment, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status.; The Comprehensive Geriatric Assessment (CGA) is a composite of assessment scales evaluating physical, psychological, and social well-being, and is the recommended tool for evaluating an older cancer patient and determining appropriateness of therapy.; The patient will receive a FitBit TM to wear for 4 days. Number of steps/day will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of geriatric abnormalities detected. (Tool used: Comprehensive Geriatric Assessment)	Investigators will test the proportions of patients having at least one abnormality detected by the Comprehensive Geriatric Assessment that was missed in the standard clinical assessment compared to a null-hypothesis rate of 5%. The Comprehensive Geriatric Assessment includes the following scales: Eastern Cooperative Oncology Group Performance Status, Self-rated Performance Status, Katz Activities of Daily Living scale, Lawton Instrumental Activities of Daily Live Scale, Timed Up and Go, Number of Falls in past 6 months, Medical Social Support Scale, Geriatric Depression Scale, National Comprehensive Cancer Center Distress Thermometer, Blessed Orientation Memory Concentration Scale, Charlson Comorbidity Index, Body Mass index,Mini Nutritional Assessment, Cancer and Aging Research Group Chemotherapy Toxicity Prediction Calculator, Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy scale	18 Months
Percentage of treatment plan changes. (Count # of treatment changes 2-3 months after comprehensive geriatric assessment. Site coordinators will complete follow-up chart review of each patient to see what, if any, changes were made)	Investigators will assess the percentage of physician reported cases whose treatment plan was modified due to responses on the Comprehensive Geriatric Assessment.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider perception (Review of Geriatric Assessment Questionnaire)	Measurement of provider perception of the efficacy and feasibility of the didactic educational session via questionnaire	18 months
Fitbit assessed functional status. Fitbit data: step count	We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between step count, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.	18 months
Fitbit assessed functional status. Fitbit data: distance logged	We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between distance logged, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.	18 months
Fitbit assessed functional status. Fitbit data: moderately active, lightly active, and sedentary minute categorization.	We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between moderately active, lightly active, and sedentary minute categorization, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.	18 months
Fitbit assessed functional status. Fitbit data: floors climbed	We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between floors climbed, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.	18 months
Fitbit assessed functional status. Fitbit data: calories burned	We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between calories burned, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.	18 months
Fitbit assessed functional status. Fitbit data: heart rate	We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between heart rate, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.	18 months

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Collaborators: Eli Lilly and Company; National Comprehensive Cancer Network

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 20-8006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No